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CGMP Violations at Cytosol Laboratories

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FDAs New England District Office again finds CGMP violations at Cytosol Laboratories.

Regulatory Problems with Exact Science Assay

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FDA says Exact Sciences PreGen-Plus colorectal screening assay is being marketed without an FDA approval or clearance.

Amitiza DTC Campaign Launched

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Takeda launches a DTC campaign to encourage constipation sufferers to Move to Amitiza.

Bill Would Ratchet-up FDA Enforcement on OTC Drugs

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Senators Kennedy and Waxman introduce legislation to give FDA authority to remove unsafe over-the-counter (OTC) drug products with...

Alternative Media More Important to DTC Marketers

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Manhattan Research says alternative media will continue to become a larger share of the DTC media and marketing strategy mix.

TAP Backs Prostate Cancer Football Tie-in

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The Prostate Cancer Education Council teams with TAP in a program to increase the number of men screened for prostate cancer.

Workshop on Adolescent OTC Drug Use

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Federal Register Notice: FDA, NIH, and the Consumer Healthcare Product Association plan a public workshop 12/6-7 on adolescent OTC...

Panel to Discuss Genentechs Avastin

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Federal Register Notice: FDAs Oncologic Drugs Advisory Committee will meet 12/5 to discuss Genentechs supplemental BLA for Avastin...

Cultured Epidermal Autografts Must Be Tracked

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FDA adds cultured epidermal autografts to the list of medical devices that must be tracked.

FDA Selects Risk Communication Panel Members

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FDA selects 15 panel members for its newly formed Risk Communication Advisory Committee, whose duties will begin early next year.